Ankasa Regenerative Therapeutics, Inc. (Ankasa) is developing ART352-L, a liposomal formulation of recombinant human Wnt3A protein, that is applied ex vivo, to harvested autologous bone grafts (autograft) to enhance the osteogenic properties of the autograft prior to reimplantation in orthopedic surgeries. This is a phase 1/2 open label safety evaluation of ART352-L treated autologous bone grafts in patients undergoing posterolateral lumbar spinal fusion to treat single level degenerative spondylolisthesis. The primary objective of the study is to evaluate the safety and tolerability of ART352-L treated local bone autografts in patients being treated for this condition, with the secondary objective to evaluate the rates of early and overall spinal fusion. Additionally, changes in patient mobility and quality of life measures from baseline following treatment with ART352-L will be evaluated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
recombinant human Wnt3a protein delivered on liposomes to local autologous bone graft during posterolateral fusion procedures
Keck School of Medicine, University of Southern California
Los Angeles, California, United States
RECRUITINGMayo Clinic
Rochester, Minnesota, United States
RECRUITINGWexner Medical Center, The Ohio State University
Columbus, Ohio, United States
RECRUITINGSafety and Tolerability
Incidence of adverse events and adverse events of special interest
Time frame: 2 weeks
Safety and Tolerability
Incidence of adverse events and adverse events of special interest
Time frame: 8 weeks
Safety and Tolerability
Incidence of adverse events and adverse events of special interest
Time frame: 26 weeks
Safety and Tolerability
Incidence of adverse events and adverse events of special interest
Time frame: 52 weeks
Safety and Tolerability
Incidence of adverse events and adverse events of special interest
Time frame: 104 weeks
Rate of early fusion
Rate of early fusion using Lenke scoring of computed tomography (CT) scans
Time frame: 26 weeks
Rate of fusion
Rate of fusion using Lenke scoring of CT scans
Time frame: 52 weeks
Rate of fusion
Rate of fusion using Lenke scoring of CT scans
Time frame: 104 weeks
Oswestry Disability Index
Change from baseline in Oswestry Disability Index
Time frame: 8 weeks
Oswestry Disability Index
Change from baseline in Oswestry Disability Index
Time frame: 26 weeks
Oswestry Disability Index
Change from baseline in Oswestry Disability Index
Time frame: 52 weeks
Oswestry Disability Index
Change from baseline in Oswestry Disability Index
Time frame: 104 weeks
Short Form-36 (SF-36)
Change from baseline in Short Form-36 (SF-36) score
Time frame: 8 weeks
Short Form-36 (SF-36)
Change from baseline in Short Form-36 (SF-36) score
Time frame: 26 weeks
Short Form-36 (SF-36)
Change from baseline in Short Form-36 (SF-36) score
Time frame: 52 weeks
Short Form-36 (SF-36)
Change from baseline in Short Form-36 (SF-36) score
Time frame: 104 weeks
Visual Analog Scale (VAS) Pain
Change from baseline in Visual Analog Scale (VAS) Pain assessment
Time frame: 8 weeks
Visual Analog Scale (VAS) Pain
Change from baseline in Visual Analog Scale (VAS) Pain assessment
Time frame: 26 weeks
Visual Analog Scale (VAS) Pain
Change from baseline in Visual Analog Scale (VAS) Pain assessment
Time frame: 52 weeks
Visual Analog Scale (VAS) Pain
Change from baseline in Visual Analog Scale (VAS) Pain assessment
Time frame: 104 weeks
Patient Reported Outcomes Measurement Information System (PROMIS) - Global 10
Change from baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Global-10 Score
Time frame: 8 weeks
Patient Reported Outcomes Measurement Information System (PROMIS) - Global 10
Change from baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Global-10 Score
Time frame: 26 weeks
Patient Reported Outcomes Measurement Information System (PROMIS) - Global 10
Change from baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Global-10 Score
Time frame: 52 weeks
Patient Reported Outcomes Measurement Information System (PROMIS) - Global 10
Change from baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Global-10 Score
Time frame: 104 weeks
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